Innovation Project Manager

Vice President - Government Relations & Public Affairs, Africa

Cyber Security Sales Specialist

Line Manager (Improvement)

Supervisor III Materials Planning

Senior Software Engineer I

Manager, Analytical Quality Assurance

Senior Devops Engineer

Site Investigation Lead, Quality Assurance

Senior Manager Quality

Responsibilities: <ul><li>In charge of New Product management and acting as project leader for all NPDs</li><li>Provide full accountability for project schedules, project management and performance requirements for innovation pipeline&nbsp;</li><li>Build team to address the project goals and objectives, accountable for overall project success-including cost, schedule, quality, and scope management</li><li>Provide guidance and motivation to project teams to successfully achieve project goal and corporate initiatives</li><li>Coordinate the efforts of the team to develop an integrated project plan and risk analysis with action plans to mitigate the risks</li><li>Report project status, issues and implemented solutions as well as evaluations and assessments of the results</li><li>Driving Lift &amp; Launch/Commercialization projects for total BU via Project Now for effective and timely launch management</li><li>Working with global team on Project Now process training and understanding</li></ul> Requirements: <ul><li>Full-time bachelor’s degree, and above</li><li>Demonstrate a strong understanding of supply chain processes and planning analysis. Experience with Supply Chain Planning or Project management is preferred&nbsp;</li><li>More than 5 years’ experience in management level in multinational companies, experience in supply chain management or project management, FMCG (Food) is preferred.&nbsp;</li><li>PMP certified professional is desirable</li><li>Good command of both written and spoken English. This position requires frequently communicating with foreigners</li><li>Good problem-solving skills, good communication skills and teamwork spirit.</li><li>Excellent skill in using office software, e.g., MS project, PPT, Excel</li></ul>

Role Description <ul><li>The VP of Government Relations &amp; Public Affairs (GR/PA) Africa role aims to enhance business value by positioning our client favourably with governments and civil society in the Africa region. The plurality of Africa’s 53 countries, with their constituencies, cultures, interests, and agendas pose a significant challenge for effective government relations and public affairs, as does unbridled social and political change and substantial ABC issues.</li><li>Advises on political systems, government processes and key personalities within government and civil society for the countries within the region;</li><li>Sets up systems for collecting, interpreting and disseminating intelligence from politics, government and related sectors as reliable input for corporate and business decision-making;</li><li>Advises Our client’s corporate functions and business units on interpreting underlying nuances and cultural subtleties involved in government decision-making;</li><li>Anticipates potential issues from government systems for prompt escalation to Our client’s leadership;</li><li>Identifies significant country and regional political events and trends for inclusion in GR strategies;</li><li>Determines the impacts of regional government policies, tax, finance and regulatory developments on Our client’s business and advises on appropriate strategies and plans for response;</li><li>Assesses complex political and social systems and provides appropriate advice to the regional team.</li><li>The role is expected to maintain a robust understanding of the political environment and drivers for government and civil society stakeholders (local, regional and federal) and be in tune with the cultures, societies and nuances of the countries making up the region. He/she will:</li><li>Work closely with businesses and functions to secure opportunities and manage risks;</li><li>Engage with the government to shape regulatory frameworks and influence policy, advocating on behalf of and interests;</li><li>When decisions are considered, provide balanced perspectives that integrate business, functional, geographical, and temporal perspectives;</li><li>Work together with the business in developing a government-specific Customer Value Proposition that differentiates Our client from its competitors as a partner of choice;</li><li>Map relationships and engagements with government and civil society stakeholders.</li><li>The priority for the Head of GR/PA Africa is to support Our client by providing strategic advice to the business on the one hand and achieving a maximum degree of influence over the regulatory environment in which the company operates on the other, with the central objective of preserving and building the business value. In addition, the role monitors, identifies and influences the operating environment as affected by statutory, legislative and regulatory governmental actions, whether local, regional or federal, that may affect Our client’s operations.</li></ul> Key Responsibilities: <ul><li>The incumbent is expected to possess an understanding of the regional, country and local businesses, political trends and key decision-makers/influencers, and an understanding of the critical drivers for Our client’s Group success.</li></ul> He/she must: <ul><li>Deliver superior policy, country and stakeholder analysis and engagement plans that help to inform credible strategies, often on short notice.</li><li>Develop a robust regional strategy to manage government stakeholders, including identification, engagement planning and relationship management</li><li>Anticipate/monitor policy change and interpret political drivers. Identify business threats and opportunities arising from statutory, legislative or other regulatory governmental action, including mitigation activities.</li><li>Support business leaders in their engagements with decision-makers. - Devise and implement advocacy plans (setting out desired policy outcomes in support of business goals, developing position papers, running engagement programs, etc.) in cooperation with the businesses, functions and in-country resources. - Leverage the informal and formal workings of government, embassies and associations to support the delivery of our clients business objectives.</li><li>Ensure coordination and maximise synergies among GR/Public Affairs, other Non-Technical Risk functions, and the relevant businesses.</li><li>Share GR/Public Affairs best practices with business representatives and actively develop local resources in-country where practical.</li><li>Ensure absolute compliance with applicable government ABC, transparency and ethical standards, and Our client’s Group rules and policies.</li></ul> Requirements: <ul><li>Confident, trusted and mature individual with a minimum 12 years experience in a mix of strategic consulting, analytical, business, government /diplomatic and Regulatory Affairs/Government Relations and Public Affairs roles;</li><li>JD or Masters degree in a relevant area of study (International Relations, Political Science, Public Policy, etc.);</li><li>Ability to understand how technical language in legislative and regulatory proposals could affect Our client’s operations, identify business implications and synthesise policy documents;</li><li>A solid network of political stakeholders within relevant bodies throughout African countries;</li><li>High degree of discretion; unquestioned and uncompromising personal and business integrity;</li><li>Capacity to multi-task and manage complexity and highly fluid situations; - Ability to manage and deliver against compressed deadlines;</li><li>Strong influencing/motivating skills and ability to drive delivery through others;</li><li>Highly developed interpersonal skills, able to work effectively with a wide range of internal and external stakeholders at all levels;</li><li>Experience in Issues Management and Crisis Management;</li><li>Good knowledge of governance and business control frameworks. Evidence of strong analytical skills</li><li>Can-do attitude in accomplishing what is necessary, either through own efforts or through others</li><li>Outstanding communicator; excellent command of English in written and spoken form required; advanced command of at least one additional African language (e.g., French) is a significant advantage.</li><li>Ability to work effectively in cross-cultural and diverse stakeholder environments. Good negotiator and coalition builder.</li><li>Considerable experience in African regulatory frameworks and processes is a requirement.</li></ul>

Responsibilities: <ul><li>Indian enterprise sector is going through huge digital transformation.</li><li>Areas like Cloud adaption, Advanced Analytics, AI, IOT, Block chain &amp; Robotic Process Automation, Information Security are key building block towards this transformation.</li></ul> You would be responsible for Building Security Business pipeline &amp; achieve the Security Annual targets in the large enterprise segment <ul><li>Lead Large Customer Engagement with CISO level conversation within top enterprises and conglomerate.</li><li>Support Sales Account Management (AM’s) as Cyber Security Sales Specialist in large complex projects (comprising of Zero Trust Architecture, Securing cloud work loads, transforming SOC, Micro segmentation and others)</li><li>Understand the client/sector requirements and Map Security products &amp; Services &amp; Build Solution Stack for Sales Account Managers</li><li>Understand NIST, CERTIN guidelines, mitre att&amp;ck framework, OT Security. Good understanding of Security products.</li><li>Well engaged with Tier-1 &amp; Tier-2 SI</li><li>Drive Security product sales within commercial segment in Manufacturing, PSU, ITeS, Digital Native and Pharma</li></ul> Who Youll Work With <ul><li>GSSO – SE team.</li><li>Account Manager.</li><li>Product Engineering BU across vertical.</li><li>Regional SE Team.</li><li>Regional Channel Team.</li></ul> Requirements: <ul><li>8-10 Years of experience in Security OEM / Service Provider Environment in managing Sales/ Pre-Sales/Product Management function</li><li>Good understanding of business scenarios with solution expertise to formulate a realistic and executable strategy for Security adoption among enterprises.</li><li>Possess blend of technology expertise across various cyber security vendors, enterprise networks, datacenter, cloud networking and Information systems security.</li><li>Good connects with Cybersecurity decision makers in enterprises</li><li>Lead Large Customer Engagement with CISO level conversation within top enterprises and conglomerate.</li><li>Support Sales Account Management (AM’s) as Cyber Security Sales Specialist in large complex projects (comprising of Zero Trust Architecture, Securing cloud work loads, transforming SOC, Micro segmentation and others).</li><li>Understand the client/sector requirements and Map Security products &amp; Services &amp; Build Solution Stack for Sales Account Managers</li><li>Understand NIST, CERTIN guidelines, mitre att&amp;ck framework, OT Security. Good understanding of Security products.</li><li>Well engaged with Tier-1 &amp; Tier-2 SI</li><li>Drive Security product sales within commercial segment in Manufacturing, PSU, ITeS, Digital Native and Pharma</li></ul>

Responsibilities: <ul><li>Responsible for building capabilities through the deployment of the AM COE to enable standard process standards to be embedded and drive improved and sustainable operational results within the site.&nbsp;</li><li>Facilitate monthly performance AM CoE review with the site AM CoE members.&nbsp;</li><li>Participate in monthly KWS call with the Regional Lead of AM CoE.</li><li>Lead governance process to ensure the effective delivery of the AM program and activities.</li><li>Actively engage with the Regional CoE lead to devise strategy and execution of existing and future AM CoE Phase development and deployment.</li><li>Ensure the use of AM tools are being adopted to drive business process excellence and deliver business results, while developing, training, and supporting cross functional teams across the site on AM tools.</li><li>Support the implementation of Digitalization on AM apps at site level.&nbsp;</li><li>Provide training on AM CoE tools.&nbsp;</li><li>Set targets and ensure key performance metrics are available to be published for AM, updating key stakeholders on a regular basis, escalating issues accordingly to the appropriate channels.&nbsp;</li><li>Ensures the use of best practices and applies lessons learned from previous projects; shares lessons learned with other project management team members. Prove linkage of key performance indicators to business process effectiveness. Document and institutionalize controls.&nbsp;</li><li>Responsible for supporting the execution of relevant projects within assigned area / shift.</li><li>Responsible for monitoring, analysis and keeping the control of the process for the line by strict monitoring and variation analysis of the production plan.</li><li>Ensures that the personnel comply with Safety and Food Safety regulatory requirements throughout their lines.</li><li>Accountable for participating in the Safety Seven program by performing the Gemba walks while ensuring that operations personnel comply with all the policies, programs and activities focused on preventing injuries, sickness and environmental sustainability. All this, through safe behaviors, K-Value alignment and the belief that all injuries are preventable.</li><li>Accountable for participating &amp; close on the identified actions from the Gemba walks (Golden Six) and participates in the scheduled walks.</li><li>Responsible for complying with good manufacturing practices. If a food safety variation is identified, this person is responsible for final reporting together with Line Manager and following up on corrective actions after agreement with relevant department such as QA, Engineering &amp; Technical team.</li><li>Ensures the implementation and follow up of actions resulting from root cause analysis, enabling problem-solution sessions related to the equipment and continuous improvement.</li><li>Active participation, analyses &amp; understand with other COE’s, all the line shutdowns, variations, OEE Trends, waste and generates action to avoid them.</li><li>Leads improvement projects for the line oriented to generate savings and increase productivity to directly impact the OEE and comply with the plant savings pipeline.</li><li>Responsible for giving weekly and monthly visibility of all activities related to their line by giving service needs for their lines, therefore job planned accordingly.</li><li>Ensures compliance with the company Work Systems (KWS) culture across all Supply Chain functions to enhance ways of working driving towards being KWS compliant Manufacturing Plant.</li><li>Responsible for managing the operation team (HR process): vacation, absence, leaves, extra hours, as well as execution of disciplinary actions.</li><li>Ensures the technical and leadership competency development of their Shift Managers &amp; development of the operative personnel.</li><li>Maintains high motivation, productivity and work environment levels among the production personnel by establishing and keeping permanent contact and good communication to identify their needs and concerns.</li><li>Other duties as assigned.</li></ul> Requirements: <ul><li>This position requires the applicant who is tertiary educated in a manufacturing or other supply chain operations discipline.</li><li>Demonstrated ability to manage complexity coupled with strong problem solving, negotiating, and decision-making skills.</li><li>Strong knowledge of manufacturing within a FMCG operation.</li><li>Experience in implementing lean manufacturing techniques., AM, continues improvements tools in processes.</li><li>Strong people management is required coupled with the ability to work cross functionally across the organization.&nbsp;</li><li>Able to communicate and influence at all levels of the organization.</li></ul>

Responsibilities: <ul><li>Guarantee the application of planning and control policies of the supply chain focused on efficiency and service level.</li><li>Coordinate and verify the compliance of areas that comprise the supply chain (planning and purchasing).</li><li>Lead the area and implement the development of new innovation processes within the operation and practice of the supply chain.</li><li>Attend internal and external audits of the area.</li><li>Establish controls and improvements to achieve high inventory reliability.</li><li>Recruit and train the appropriate personnel for the different positions in the department.</li><li>Ensures compliance in responsibilities, hiring, training and performance evaluation and professional development of assigned employees with an action plan to improve performance and motivation of the team.</li><li>Achievement of goals established by the organization.</li></ul> Daily activities: <ul><li>Ensure internal sourcing and delivery of products to customers on time and with the required quality.</li><li>Oversee planning and purchasing processes.</li><li>Periodic activities:</li><li>Review ERP parameters and information to ensure optimal performance.</li><li>Review and analyze current demand vs. Forecast</li><li>Projection of loads and capacities for production.</li><li>Eventual activities:</li><li>Transfers (line or equipment migrations)</li><li>Quality audits</li><li>Participation and follow up in assigned continuous improvement projects.</li></ul> Requirements: <ul><li>Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field; or equivalent practical experience.</li><li>At least 5+ years’ experience in RPA development or automation solutions design.</li><li>UI Path certification is highly desirable.</li><li>Proficiency in RPA tools such as UI Path, Power Automate, PowerApps and familiarity with other platforms like Blue Prism or Automation Anywhere.</li><li>Strong programming skills in Python, Selenium etc with experience in developing automation scripts and API integrations.&nbsp;</li></ul>

Role Description: <ul><li>BASIC FUNCTIONS: This position performs complex research, design, and software development assignments within a software functional area or product line, and provides direct input to project plans, schedules, and methodology in the development of cross-functional software products.</li><li>This position performs software design — typically across multiple systems; mentors more-junior members of the team; and talks to users/customers and translates their requests into solutions.</li></ul> Responsibilities: <ul><li>Interface with other technical personnel or team members to finalize requirements.</li><li>Write and review portions of detailed specifications for the development of complex system components.</li><li>Complete complex bug fixes.</li><li>Work closely with other development team members to understand complex product requirements and translate them into software designs.</li><li>Successfully implement development processes, coding best practices, and code reviews.</li><li>Operate in various development environments (Agile, Waterfall, etc.) while collaborating with key stakeholders.</li><li>Resolve complex technical issues as necessary.</li><li>Train entry-level software engineers as directed by department management, ensuring they are knowledgeable in critical aspects of their roles.</li><li>Keep abreast of new technology developments.</li><li>Design and work with complex data models.</li><li>Mentor less-senior software developers on development methodologies and optimization techniques.</li><li>All other duties as assigned.&nbsp;</li></ul> Requirements: Qualifications <ul><li>4+ years of Software Engineering experience.</li><li>BS Engineering/Computer Science or equivalent experience required.</li></ul> Technical Skills <ul><li>Advanced knowledge of software development methodologies (e.g., Agile, Waterfall).</li><li>Strong proficiency with data manipulation language including optimization techniques.</li><li>Strong understanding of normalized/dimensional data modeling principles.</li><li>Strong knowledge of multiple data storage subsystems.</li><li>Expertise in development languages including but not limited to: Java/J2EE, JavaScript, JSP, C/C++, HTML, XML, SQL, Windows, UNIX, and .Net.</li><li>Strong research skills.</li><li>Strong knowledge in industry best practices in development.</li><li>Knowledge in using and developing applicable tool sets.</li><li>Ability to interface competently with other technical personnel or team members to finalize requirements.</li><li>Ability to work well with internal and external technology resources.</li><li>Knowledge of test-driven development.</li><li>Ability to write and review portions of detailed specifications for the development of complex system components.</li><li>Ability to complete complex bug fixes.</li><li>Good oral and written communication skills.</li></ul>

Responsibilities: Accountability AQA Management <ul><li>Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines.</li><li>Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation.</li><li>Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting.</li><li>Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails.</li><li>Collaborate with QC, QA, and R&amp;D departments to support method validations, transfers, and investigations.</li><li>Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries.</li><li>Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents.</li><li>Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise.</li><li>Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness.</li><li>Mentor, coach, and develop the AQA team to build a high-performing quality organization.</li></ul> Workload Management <ul><li>Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> SOPs <ul><li>Review/Approve SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li></ul> Staff Development <ul><li>Evaluate potential candidates for QA, performance evaluation of direct reports.</li><li>Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing.</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field (master’s or Ph.D. preferred).</li><li>Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control.</li><li>Proven leadership or supervisory experience in a GMP-regulated environment.</li><li>Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills..</li></ul> Knowledge <ul><li>Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia.</li><li>Knowledge of pharmaceutical manufacturing processes and laboratory practices.</li><li>Familiarity with regulatory submission requirements (ANDA, NDA, etc.).</li><li>Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise).</li></ul> Skills &amp; Abilities <ul><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills.</li><li>Strong attention to detail with a commitment to quality and compliance.</li><li>Effective leadership, team management, and interpersonal communication.</li><li>Ability to prioritize and manage multiple tasks in a fast-paced environment.</li><li>Proficient in technical writing and reviewing complex data and reports.</li></ul> Physical Requirements <ul><li>Ability to sit or stand for extended periods.</li><li>Occasionally lift up to 25 pounds.</li><li>Use of personal protective equipment (PPE) as required in laboratory or production areas.</li><li>Ability to work in office, laboratory, and manufacturing settings as needed.</li><li>The work environment is representative of a group laboratory environment.</li></ul>

Responsibilities: You will make an impact in the following way: Advanced Troubleshooting:&nbsp; <ul><li>Diagnose and resolve complex issues related to the cloud application, involving in-depth of the application architecture and infrastructure.</li></ul> Root Cause Analysis:&nbsp; <ul><li>Conduct thorough root cause analyses for recurring issues, implement preventive measures, and provide insights for continuous improvement.</li></ul> Automation and Scripting:&nbsp; <ul><li>Develop and utilize scripts and automation tools to streamline processes, improve efficiency, and reduce manual intervention in issue resolution.</li></ul> Documentation:&nbsp; <ul><li>Maintain comprehensive documentation for troubleshooting procedures, system configurations, and resolutions to facilitate sharing and future reference.</li></ul> Customer Communication:&nbsp; <ul><li>Effectively communicate with customers, providing clear and timely updates on issue resolution progress and collaborating on preventive measures.</li><li>You will be responsible for High Performance, Scalable, Robust, and Secure Common SaaS Framework based on AWS/OCP infrastructure.&nbsp;</li><li>This framework allows customers to configure provision, upgrade &amp; monitor various network functions in carrier grade enterprise &amp; telecom networks.&nbsp;</li></ul> Security and Compliance:&nbsp; <ul><li>Ensure the security of systems and applications, adhere to compliance requirements, and implement best practices for data protection.</li></ul> Collaboration:&nbsp; <ul><li>Collaboration with internal and external stakeholders.&nbsp;</li><li>Work closely with development, QA, and operations teams to foster a culture of collaboration and continuous improvement.&nbsp;</li><li>Collaborate with client’s team to gather the requirements.</li></ul> Training and Mentorship:&nbsp; <ul><li>Provide guidance and mentorship to junior team members and promote sharing within the organization.</li><li>Troubleshoot and fix any customer issues identified internally or in the production deployments.</li></ul> Requirements: <ul><li>5-8 years of Experience in DevOps (Jenkins, AWS services, Kafka, Grafana, elastic search, Bitbucket, Git, Deployment, Documentation, Root Cause Analysis reports, Customer interactions etc)</li><li>Experience with Cloud-native SaaS development &amp; virtualization technologies, for example, AWS, ESXi, KVM, HyperV would be a plus.&nbsp;</li><li>Extensive experience in developing distributed system design.</li><li>Prefer experience with microservice architecture, large scale, public cloud, IAM</li><li>Strong knowledge of containerization technologies like Kubernetes and Docker.&nbsp;</li><li>Strong knowledge in public cloud technologies (preferably AWS) and on-premises setups.</li><li>Good knowledge of analysing backend, frontend code whenever required and able to perform some tests as per customer issues.</li><li>Experience with CI/CD tooling like Jenkins etc.</li><li>Experience with version control system like Git, Bitbucket.</li><li>Experience with IaaC (Infrastructure as a Code) tools like Terraform.</li><li>Familiarity with agile development methodologies.&nbsp;</li><li>Lead and participate in various scrum ceremonies.</li><li>Good knowledge of observability tools like Kibana, Elastic stack, Prometheus stack etc.</li><li>Good knowledge of Linux operating system</li><li>Good knowledge of programming languages like Shell scripting, Python etc.</li><li>Knowledge of REST API, API gateways&nbsp;</li><li>Effective communication skills – written, spoken, listening and presentation.&nbsp;</li><li>Great Team player and experience working with global teams and global organizations.&nbsp;</li><li>Bachelor’s in computer science or equivalent.&nbsp;</li><li>Preferably a master’s degree in computer science.</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Responsibilities: People Management (20%): <ul><li>Lead the quality control department, including 4 teams,1 Supervisor and 5 engineers, 25 QA inspectors, Allocate and balanced work across direct reports. </li><li>reviewed and provided timely performance feedback to direct reports.&nbsp;</li><li>mentored, developed and motivated them. guide resolve tough people/functional issues in the team.&nbsp;</li><li>submit manpower application.&nbsp;</li><li>interview candidates and provide feedback to achieve the section performance target, retain and develop key talent Assure compliance to requirements and optimization of process capabilities to ensure product quality, customer service, and cost-effectiveness. Led the team to reduce DPPM, customer complaints, customer returned values, and quality costs.</li></ul> Procedure &amp; Policy (5%): <ul><li>Check the department policies initiate the policy change and prepare the related materials and follow up and monitor the policy execution.&nbsp;</li><li>to ensure the procedures and policies in line with corporate standards are well executed.</li></ul> Budgeting (5%): <ul><li>Communicate with functional teams and prepare department budget and work plan annually and compare the expenses with the budget monthly.&nbsp;</li><li>summarize the result, analyze and report to department director to propose practical department budget and conduct effective control.</li><li>Working with the management team to develop a quality plan and set up annual goals, build a strong implementation plan, and monitor to ensure target achievement.&nbsp;</li><li>Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.</li></ul> Quality control (15%): <ul><li>Lead the incoming material section and supplier management, facilitate quality improvement, and follow up on the improvement results.</li><li>Monitor the operation to comply with working instructions and find potential risk and take necessary actions.</li><li>Monitor the outgoing product quality control to ensure the resources are properly allocated and working instructions are well understood and executed by inspectors. Monitor the training conducted.</li><li>Monitor the on-site application of quality tools.in order to ensure effective quality control and meet quality requirement</li></ul> Customer complaint (15%): <ul><li>Monitor the customer complaints analysis and follow-up corrective actions.</li><li>Initiate and organize monthly quality meetings to review the quality issues and facilitate improvement actions.</li><li>Negotiate with customers about quality issues solving.</li><li>Conduct regular visits to customers and keep good relationships.</li><li>Monitor the customer complaint follow-up actions and feedback from the system in China.</li><li>Evaluate the RMA and follow up RMA dispose to timely solve customer complaint issues in cost-effective way and improve customer satisfaction.</li></ul> Quality issue (20%): <ul><li>Guide the engineers to solve on site quality issues and take preventive actions. </li><li>help to solve cross-function issues and evaluate and balance the quality, delivery, and cost to solve quality issues timely and prevent similar cases happen. </li><li>Lead problem-solving of supplier-related defects, lead supplier improvement initiatives analyze manufacturing and supply chain quality data and lead problem-solving activities.</li></ul> Quality Improvement (15%): <ul><li>Initiate and monitor the monthly cross audit, review the results, and follow up the corrective actions. review the department 6 Sigma improvement monthly and monitor the engineers conduct of daily quality improvement in order to drive continuous quality improvement.</li></ul> Reporting (5%): <ul><li>Prepare the operation performance report and send to GM.</li><li>Collect and analyze the quality-related data and report to BU Quality</li><li>Team timely and accurate report to management and related parties</li></ul> Requirements: Education, Technical Qualification:&nbsp; <ul><li>Bachelors degree (Major in engineering)</li><li>8-10 years working experience in quality areas including 2 years of people management Effective bilingual</li></ul>

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Manager, Analytical Quality Assurance

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